Controlled Randomized Clinical Trial of Containment of the Elevator Muscle of Upper Lip and Wing of Nose Technique Versus Conventional Lip Repositioning for Treatment of Gummy Smile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Measuring smile line (the amount of gingival display in millimeters)
研究概览
简要总结
The goal of this clinical trial is to compare and evaluate the effectiveness of conventional and modified lip repositioning for the treatment of gummy smile.
The main question it aims to answer:
Which of these treatment modalities (conventional lip repositioning and containment of the elevator muscle of the upper lip and wing of nose (EMULWN)) has the most durable and least relapse in the treatment of gummy smile?"
Researchers will compare:
- The primary outcome was the decrease in excessive gingival display by measuring smile line (gingival display) and smile index before and after treatment modalities.
- The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction.
详细描述
For patients seeking long-term correction of excessive gingival displays, there are different treatment modalities. Both lip repositioning and muscle traction techniques showed improvement in the decrease in the amount of gingival display, while the containment surgery of the muscle of the upper lip and wing of the nose showed durable and satisfactory esthetics with less patient discomfort and less pain immediately after the procedure and needs more time to study or may need some modification. Also, lip repositioning showed satisfactory results to the patients but with more pain immediately after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blinded technique
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 18 and 38 years.
- •Gummy smile ranging between 4 and 6 mm, due to short upper lip and hyperactive lip elevator muscles (lip mobility >8 mm).
- •Good periodontal health based on the examination of the gingival inflammation index, bleeding index, and probing the depth of gingival pockets.
- •Healthy patients or people with well-controlled systemic disease.
排除标准
- •Pregnant or lactating women.
- •Less than 3 mm of attached gingiva that might create difficulties in flap design, stabilization, and suturing.
- •Vertical maxillary excess of more than 6 mm.
- •Poorly controlled systemic diseases that preclude local anesthesia.
- •Altered passive eruption, which needs gingivectomy or an apically positioned flap.
- •Skeletal causes of gummy smile as protruded maxilla.
结局指标
主要结局
Measuring smile line (the amount of gingival display in millimeters)
时间窗: at baseline, after one month, after 3 months and after 6 months
The first primary outcome of the study was to measure the change in excessive gingival display by measuring smile line (the amount of gingival display in millimeters) before and after treatment. 1/Smile line (gingival display) Type 1: Very high smile line: 2 mm or more of marginal and attached gingiva visible or more than 2 mm of root or gingiva apical to the cemento-enamel junction visible for the healthy but reduced periodontium. This smile is classified as a "gummy smile." Type 2: High smile line: Between 0 and 2 mm of marginal and attached gingiva visible or between 0 and 2 mm visibility of root and gingiva apical to the cemento-enamel junction visible for the reduced and healthy periodontium. Type 3: Average smile line: Gingival embrasures only visible. Type 4: Low smile line: Gingival embrasure and cemento-enamel junction not visible.
Measuring smile index ratio before and after treatment.
时间窗: at baseline, after one month, after 3 months and after 6 months
The second primary outcome of the study was to measure the change in excessive gingival display by measuring smile index ratio which is (intercommissural width/interlabial gap) to visualize and quantify the frontal smile. The ratio is used for comparing smiles among patients. The lower the smile index, the less youthful the smile appears.
次要结局
- Patient Satisfaction with Their Smile(at baseline, one month, 3 months and 6 months)
- Patient discomfort(immediately after treatment)